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Led by Astellas Pharma Global Development, Inc. · Updated on 2026-06-26
40
Participants Needed
16
Research Sites
N/A
Total Duration
Researchers are evaluating gilteritinib in adults with locally advanced or metastatic ALK-positive non-small cell lung cancer NSCLC who have stopped responding to prior ALK inhibitor treatments such as alectinib or lorlatinib. This study aims primarily to assess the safety and tolerability of gilteritinib for these patients. The need arises because some patients develop resistance to current ALK inhibitors, and gilteritinib, approved for certain leukemias, may block changes in the ALK gene that cause treatment resistance. Participants will take gilteritinib tablets once daily in 28-day cycles, starting at a lower dose with the option to increase to a higher dose if tolerated and stable disease is observed after two tumor scans. Treatment continues until cancer progression, intolerable side effects, patient choice to stop, initiation of other cancer therapies, or death. After stopping gilteritinib, participants will have clinic visits about 7 and 30 days later for safety checks. Those without disease progression will continue regular tumor scans. Throughout the study, participants will have regular tumor scans and safety assessments including physical exams, vital signs, electrocardiograms, and laboratory tests. After finishing treatment, follow-up phone calls will occur every 12 weeks to monitor health. The study may last up to four years depending on individual responses. Researchers will measure dose-limiting toxicities, adverse events, response rates, survival, and pharmacokinetics to evaluate gilteritinibs safety and effects in this population.
CONDITIONS
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
A
Astellas Pharma Global Development, Inc.
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Astellas Pharma Global Development, Inc.
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Gilteritinib | Standard ALK‑inhibitor therapy |
|---|---|---|
| What it is | An investigational oral multi‑kinase inhibitor (gilteritinib) being tested in adults with advanced ALK‑positive NSCLC after prior ALK inhibitor therapy. | An approved next‑generation ALK tyrosine kinase inhibitor (such as lorlatinib, alectinib or brigatinib) used in similar patients who have progressed after earlier ALK inhibitors. |
| Why it’s being studied or used | To evaluate safety, tolerability and dose in patients with ALK‑positive NSCLC post prior ALK inhibitors. | To block ALK‑driven tumor growth using approved ALK inhibitors in this patient population. |
| Evidence status | Preclinical and early case data suggest gilteritinib may overcome resistance to prior ALK inhibitors. | Next‑generation ALK inhibitors have demonstrated efficacy and improved progression‑free survival in ALK‑positive NSCLC after prior ALK therapy. |
| Important risks | Safety and tolerability in ALK‑positive NSCLC remain unknown; risks derived from other indications may not apply. | Known risks include hepatitis, neurocognitive effects, hyperlipidemia depending on agent (e.g., lorlatinib associated with CNS and lipid changes). |
| Important limitations | Early‑phase study with no comparator arm and limited safety and efficacy data. | Resistance eventually develops even to approved next‑generation ALK inhibitors; long‑term control remains challenging. |
| Potential patient impact | Not yet established whether gilteritinib offers clinical benefit in this setting. | Next‑generation ALK inhibitors can delay disease progression and improve symptoms in many patients. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable, up to 4 years depending on response
Participants take gilteritinib tablets once daily in 28-day cycles. Dose may increase if tolerated and stable disease is observed after two scans. Treatment continues until disease progression, intolerable side effects, patient choice to stop, or other cancer treatment begins.
Regular tumor scans and safety assessments during treatment
Duration - Up to several years depending on participant condition
After stopping gilteritinib, participants have clinic visits about 7 and 30 days later for safety checks. Those without disease progression continue regular tumor scans. Phone calls occur every 12 weeks to monitor health after treatment ends.
2 clinic visits after treatment and ongoing phone calls every 12 weeks
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Sai-Hong Ignatius Ou, Cathleen June Park, Zhaohui Liao Arter...
https://pubmed.ncbi.nlm.nih.gov/41158152/Astellas Pharma Global Development, Inc.
Lead Sponsor
